# Synaptive Medical, Inc.

- Location (FDA's records): Toronto, CA
- FDA decisions: 10 (2014–2024): 10 510(k) clearances
- Product codes: HAW (4), LLZ (3), LNH (2), IZI (1)
- 510(k) review time since 2016: median 120 days, against 124 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 8 (6 its own)
- Recalls linked to its devices: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Carl Zeiss Surgical GmbH: 1 (https://510kreport.com/company/carl-zeiss-surgical)
- Materialise NV: 1 (https://510kreport.com/company/materialise)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- I.Z.I. Medical Products Corp.: 1 (https://510kreport.com/company/izi-medical-products)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)

## Firms that cite its devices most
- Fiagon GmbH: 1 (https://510kreport.com/company/fiagon)
- 7D Surgical, Inc.: 1 (https://510kreport.com/company/7d-surgical)

## Its most-cited devices
- K142024: Brightmatter Navigation System (2015), cited by 4
- K153281: BrightMatter Guide with Surface Trace Registration (2016), cited by 2
- K140337: Brightmatter Planning Software (2014), cited by 1
- K200327: Evry (2020), cited by 1

## Recent decisions
- K231986: Modus IR (Mar 25, 2024)
- K232981: Synq Software Version 1.3 (Oct 11, 2023)
- K200327: Evry (Apr 29, 2020)
- K183325: Modus Nav (Jul 14, 2019)
- K180394: BrightMatter Plan 1.6.0 (Mar 9, 2018)
- K160523: BrightMatter Guide with BrightMatter Pointer (Jun 24, 2016)
- K153281: BrightMatter Guide with Surface Trace Registration (Mar 30, 2016)
- K153284: Synaptive ImageDrive Pro (Mar 29, 2016)

Source page: https://510kreport.com/company/synaptive-medical